{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-10",
    "results": {
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      "cfres_id": "193010",
      "product_res_number": "Z-0944-2022",
      "event_date_initiated": "2022-03-04",
      "event_date_created": "2022-05-03",
      "recall_status": "Open, Classified",
      "res_event_number": "89975",
      "product_code": "QKP",
      "product_description": "Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test",
      "code_info": "All lots: \nUL-AG-2110-05-Q\nUL-AG-2111-02-Q\nUL-AG-2112-01-Q\nUL-AG-2112-02-Q\nUL-AG-2201-03-Q",
      "firm_fei_number": "3022161362",
      "recalling_firm": "SML Distribution, LLC",
      "address_1": "1500-1631 Lincoln Ave.",
      "city": "tyrone",
      "state": "PA",
      "postal_code": "16686",
      "additional_info_contact": "Christopher Nagle\n888-209-4406",
      "reason_for_recall": "The product was distributed without FDA authorization or clearance for marketing and distribution in the US.",
      "root_cause_description": "No Marketing Application",
      "action": "The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line \"IMPORTANT!!! Recall Notice\" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions.\n\nAs of April 9, 2022, the full recall notice can be found at www.smldistribution.com.",
      "product_quantity": "209,450 units",
      "distribution_pattern": "US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.",
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
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}